Minnesota’s Synovis gets FDA clearance for blood-flow-measurement device

ST. PAUL, Minnesota — Synovis Life Technologies Inc. has received clearance from the U.S. Food and Drug Administration for a device that measures blood flow immediately after surgical procedures in which veins have been connected.

The company’s Flow Coupler device connects blood vessels and uses a Doppler sensor to measure blood flow at the site where the veins are joined, called the anastomosis. The sensor provides surgeons with real-time information about blood flow through the site, which enables surgeons to immediate intervene if the anastomosis becomes blocked.

The device is the next-generation version of Synovis’ Coupler, which is used to connect blood vessels but doesn’t monitor blood flow.

Publicly traded Synovis, founded in 1985, divides its products into three major categories: staple-line reinforcement, soft-tissue repair and surgical tools.

In 2009, the company’s profits plummeted to $2.7 million from $11.5 million in the prior year. Sales jumped 17 percent, however, to $58 million. In a statement that was released with the company’s financial information, Chief Executive Richard Kramp credited the revenue growth to expanding the company’s surgical sales force by 40 percent and receiving European regulatory approval for its signature Veritas technology.

The technology consists of converting cow tissue into a type of scaffolding that attracts the body’s own cells and blood vessels, allowing the body eventually to remodel the repaired tissue type. Synovis hopes doctors will use Veritas to help repair kidneys, bladders, breasts, and eventually, hearts.